FDA Enforcement
Class I
Terminated
Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Recall: Z-0272-2015
·
Reported December 10, 2014
Enforcement
- Recall Number
- Z-0272-2015
- Event ID
- 69448
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Customed, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 10, 2014
- Initiation Date
- October 8, 2014
- Classification Date
- November 28, 2014
- Termination Date
- August 14, 2017
- Address
- Calle Igualdad Final #7, N/A, Fajardo, PR, 00738, United States
Description
Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Code Info
Lot numbers 140513062 140513474 140613801 140613808 140714385
Distribution
US Distribution to Florida, New York and Puerto Rico..
Quantity
480